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Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry

NCT02582034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-01-31

No results posted yet for this study

Summary

The purpose of this study is to determine whether a treatment with Therasphere which is optimized is more efficient compared to a standard treatment for patients suffering from hepatocellular carcinomas.

Conditions

  • Adenoma, Liver Cell

Interventions

RADIATION

Optimized Internal Radiation Therapy

Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental). Optimized dosimetry arm: the activity to be administered is calculated so as to deliver predictive dosimetry: * An absorbed dose to the tumor of at least ≥ 205 Gy and if possible exceeding 250 Gy or even 300 Gy * A dose at the treated healthy liver \< 120 Gy in case of lobar treatment * Dose to the treated healthy liver can exceed 120 Gy in case of segmental treatment and hepatic reserve \> 30% * A pulmonary dose \< 30 Gy for one treatment and \< 50 Gy in cumulative dose in case of multiple treatments.

RADIATION

Standard Internal Radiation Therapy

Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental).Standard dosimetry arm: the activity to be administered is calculated so as predictive dosimetry: * An absorbed dose of 120 ± 20 Gy to the treated volume (whatever the tumor absorbed dose) * A pulmonary dose \< 30 Gy for one treatment and \< 50 Gy in cumulative dose in case of multiple treatments.

Sponsors & Collaborators

  • Center Eugene Marquis

    lead OTHER

Principal Investigators

  • Etienne GARIN, Pr · Centre Eugène Marquis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582034 on ClinicalTrials.gov